VOICE: Values and Options in Cancer Care (VOICE)

Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer

The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Communication training and coaching

Detailed Description

The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.

• Study Type: Interventional
• Enrollment (Actual): 485
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Physicians

• Currently in clinical practice at participating institutions
• Oncologist that cares for patients with solid tumors
• Not planning to leave the practice during the next 6 months

Inclusion Criteria: Patients

• Currently a patient of an enrolled physician
• Age 21 years or older
• Diagnosis of advanced cancer
• Able to understand spoken English (study personnel will read materials to low literacy patients)

Inclusion Criteria: Caregivers

• Caregiver of a patient currently enrolled in the study
• Age 21 years or older
• Able to understand spoken English (study personnel will read materials to low literacy patients)

Exclusion Criteria: Physicians

• Non Physicians and physicians who are not oncologists
• Oncologists who exclusively care for patients with hematological malignancies
• Prior involvement in health-related coaching interventions

Exclusion Criteria: Patients

• Unable to complete orally-administered surveys in English
• Hospitalized or in hospice care at the time of recruitment
• Prior involvement in health-related coaching interventions
• Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma

Exclusion Criteria: Caregiver

Unable to complete orally-administered surveys in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.	Behavioral: Communication training and coaching; Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
No Intervention: Control; Patients will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Patient-centered Communication in Advanced Cancer Score	We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13	The prolonged grief (PG-13) instrument was used to measure prolonged grief. The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion. The range of the score is 10-50 with higher scores indicating more severe symptoms.	7 months
Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians	Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient. They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years. A value of 0-6 was assigned to each pair of data. 0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference. For example if the physician said 100% and the patient said 0% the score was 6. The mean scores were reported by arm.	3 years
Aim 2 Patient Well-being	Original McGill quality of life and the FACT-G assessment tools were used. For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome. For FACT-G scores range from 0 to 4. Higher score means a better outcome. Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale. Sum of the five standardized z-scores is the Aggregate QOL score. A higher Z score indicates better outcomes. The maximum possible Z-score ranged from -3.54 to 1.24.	3 years
Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment	SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.	7 months
Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life	Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization. The total scores ranged from 0-6 with higher scores indicated worse outcomes. The sums of the means for the 3 outcomes were added to provide the total score.	3 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ronald Epstein, MD, University of Rochester

Publications and helpful links

General Publications

• Epstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.
• Hoerger M, Epstein RM, Winters PC, Fiscella K, Duberstein PR, Gramling R, Butow PN, Mohile SG, Kaesberg PR, Tang W, Plumb S, Walczak A, Back AL, Tancredi D, Venuti A, Cipri C, Escalera G, Ferro C, Gaudion D, Hoh B, Leatherwood B, Lewis L, Robinson M, Sullivan P, Kravitz RL. Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer. 2013 Apr 9;13:188. doi: 10.1186/1471-2407-13-188.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: November 30, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; prognosis; Communication
• Other Study ID Numbers: 35388; R01CA140419-01A2 (U.S. NIH Grant/Contract)